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V118C

Phase 1

Pneumococcal Infection | Monoclonal antibody | Infectious Disease |Merck & Company, Inc.|Last Updated: Apr 17, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment210
FDA Designations
No designations recorded
Clinical trial landscape

V118C · 2 trials · 2 indications

Phase 1 2
NCT07300267A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002)Pneumococcal Infection
RECRUITING210 Analytics
NCT06611033A Study of V118 Formulation C (V118C) in Healthy Participants (V118C-001)Healthy
COMPLETED65 Analytics
PHASE1RECRUITING
A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002)
Pneumococcal InfectionUnlock trial analytics
PHASE1COMPLETED
A Study of V118 Formulation C (V118C) in Healthy Participants (V118C-001)
HealthyUnlock trial analytics
Study Endpoints
Primary Endpoints
Stage 1: Percentage of Participants With Immediate Adverse Events (AEs) Following Vaccination
Up to approximately 30 minutes postvaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with immediate AEs following vaccination will be reported.

Stage 1: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
Up to approximately 7 days postvaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants legally acceptable representative (LAR) are specifically asked about and record on their electronic vaccine report card (eVRC). Solicited injection-site AEs include redness, swelling, pain or tenderness and hard lump. Percentage of participants with solicited injection-site AEs will be reported.

Stage 1: Percentage of Participants With Solicited Systemic AEs
Up to approximately 7 days postvaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited systemic AEs include irritability, drowsiness, appetite lost, hives or welts, and fever. Percentage of participants with solicited systemic AEs will be reported.

Stage 1: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs
Up to approximately 28 days postvaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE is an event that is not solicited using a eVRC and that is communicated by a participant. Percentage of participants with unsolicited Systemic or Injection-Site AEs will be reported.

Stage 1: Percentage of Participants With Serious Adverse Events (SAEs)
Up to approximately 12 months postvaccination

A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Percentage of participants with one or more SAEs will be reported.

Stage 1: Percentage of Participants With Medically Attended AEs (MAAEs)
Up to approximately 12 months postvaccination

A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Percentage of participants with MAAEs will be reported.

Stage 2: Percentage of Participants With Immediate AEs Following Vaccination
Up to approximately 30 minutes after each vaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with immediate AEs following vaccination will be reported.

Stage 2: Percentage of Participants With Solicited Injection-Site AEs
Up to approximately 7 days after each vaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited injection-site AEs include redness, swelling, pain or tenderness and hard lump. Percentage of participants with solicited injection-site AEs will be reported.

Stage 2: Percentage of Participants With Solicited Systemic AEs
Up to approximately 7 days after each vaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A solicited AE is a predefined event that participants LAR are specifically asked about and record on their eVRC. Solicited systemic AEs include irritability, drowsiness, appetite lost, hives or welts, and fever. Percentage of participants with solicited systemic AEs will be recorded.

Stage 2: Percentage of Participants With Unsolicited Systemic or Injection-Site AEs
Up to approximately 28 days after each vaccination

An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE is an event that is not solicited using a eVRC and that is communicated by a participant. Percentage of participants with unsolicited Systemic or Injection-Site AEs will be reported.

Stage 2: Percentage of Participants With SAEs
Up to approximately 12 months postdose 4

A SAE is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Percentage of participants with one or more SAEs will be reported.

Stage 2: Percentage of Participants With MAAEs
Up to approximately 12 months postdose 4

A MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Percentage of participants with MAAEs will be reported.

Number of Participants with Solicited Injection Site Adverse Events (AEs)
Up to approximately 7 days after each vaccination

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants with a solicited injection-site AE will be reported.

Number of Participants with Solicited Systemic AEs
Up to approximately 7 days after each vaccination

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants with a solicited systemic AE will be reported.

Number of Participants with Immediate AEs Following Vaccination
Up to approximately 30 minutes after each vaccination

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants with Immediate AEs following vaccination will be reported.

Number of Participants with Unsolicited AEs
Up to approximately 28 days after each vaccination

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. An unsolicited AE is an AE that is not solicited using a vaccine report card (VRC) and that is communicated by a participant. The number of participants that experienced an unsolicited AE will be reported.

Number of Participants With a Serious Adverse Event (SAE)
Up to approximately 12 months after final vaccination

An SAE is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The number of participants who experience an SAE will be reported.

Number of Participants with a Medically Attended Adverse Event (MAAE)
Up to approximately 12 months after final vaccination

An MAAE is defined as an adverse event in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency room visit, office visit, or an urgent care visit with any medical personnel for any reason. The number of participants who experience an MAAE will be reported.

Number of Participants with an Event of Clinical Interest (ECI)
Up to approximately 12 months after final vaccination

An ECI includes but is not limited to: 1) An overdose defined as: A participant receiving more than 1 dose of study vaccine in a 24-hour period or more than 2 doses of study vaccine throughout the study. 2) Potential drug-induced liver injury (DILI) events defined as: An elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value that is ≥3 times the upper limit of normal (ULN) and an elevated total bilirubin lab value that is ≥2 times ULN and, at the same time, an alkaline phosphatase lab value that is \<2 times ULN, as determined by way of protocol-specified laboratory testing or unscheduled laboratory testing. 3) Potential immune-mediated disease (pIMDs) defined as: A subset of AEs that include either an established autoimmune disease(s) or Inflammatory and/or neurologic disorder(s), which might or might not have an autoimmune etiology. The number of participants who experience an ECI will be reported.

Secondary Endpoints
Stage 1: Geometric Mean Concentrations (GMCs) of Serotype-Specific Immunoglobulin G (IgG)
Up to approximately 30 days post vaccination
Stage 1: Ratio of GMCs of Serotype-Specific IgG of V118C to PCV20 [V118C/PCV20]
Approximately Day 30 postvaccination
Stage 1: Geometric Mean Fold Rises (GMFRs) of Serotype-Specific Immunoglobulin G (IgG)
Day 1 (Baseline) and approximately Day 30 postvaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
V118C (Stage 1)EXPERIMENTALParticipants will receive a single 0.5 mL intramuscular (IM) injection of V118C administered at 12 to 15 months of age.
V118C (Stage 2)EXPERIMENTALParticipants will receive a single 0.5 mL IM injection of V118C administered at 2,4,6, and 12 months of age.
PCV20 (Stage 1)ACTIVE_COMPARATORParticipants will receive a single 0.5 mL IM injection of PCV20 administered at 12 to 15 months of age.
PCV20 (Stage 2)ACTIVE_COMPARATORParticipants will receive a single 0.5 mL IM injection of PCV20 administered at 2,4,6, and 12 months of age.
V118CEXPERIMENTALParticipants receive intramuscular (IM) injection of V118C in a 2-dose regimen administered on Day 1 and Day 29.
V118EXPERIMENTALParticipants receive IM injection of V118 in a 2-dose regimen administered on Day 1 and Day 29.
PREVNAR 20™ + SalineACTIVE_COMPARATORParticipants receive one dose of IM injection of PREVNAR 20™ in a 2-dose regimen on Day 1 followed by one dose of saline on Day 29.
Interventions
NameTypeDescription
V118C (Stage 1)BIOLOGICALIM administration of V118C
V118C (Stage 2)BIOLOGICALIM administration of V118C
PCV20 (Stage 1)BIOLOGICALIM administration of PCV20
PCV20 (Stage 2)BIOLOGICALIM administration of PCV20
V118CBIOLOGICALIntramuscular Administration
V118BIOLOGICALIntramuscular Administration
PREVNAR 20™BIOLOGICALIntramuscular Administration
SalineBIOLOGICALIntramuscular Administration
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Eligibility Criteria
Age Range2 Months to 15 Months
SexALL
Healthy VolunteersYes
Study Sites14

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: Stage 1: * Is previously vaccinated with 3 routine infant doses of Pneumococcal 20-valent conjugate vaccine (PCV20) * Is 12 through 15 months of age Stage 2: \- Is approximately 2 months of age Both S...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07300267primaryCompletionDate: changed
LOWMay 24, 2026NCT07300267studyFirstPostDate: changed